Kornimate/medical-research-clean huggingface dataset:
back pain and arthroplasty in orthopedists

Conditions: Pain, Chronic; Back Pain

Summary: the relationship between arthroplasty and low back pain in orthopedists will be evaluated.


Eligibility criteria:
inclusion criteria: * those who have received specialization of orthopaedics and work as a orthopaedics surgery. * those who want to participate in the study exclusion criteria: * patients with discomfort and operation due to the low back pain * physicians in other branches
mody in young-onset diabetes in different ethnicities

Conditions: Diabetes; Maturity Onset Diabetes of the Young; Type 1 Diabetes; Type 2 Diabetes

Summary: the purpose of this study is to describe and compare the different types of diabetes that exist in people from white european and south asian origin in the uk (united kingdom) who are diagnosed with diabetes before they turn 30 years old. by doing this we hope to identify cases of mody (maturity onset diabetes of the young), which is a rare genetic cause of diabetes that is frequently misdiagnosed. identifying mody cases is important, as the treatment may differ to conventional treatment for type 1 or type 2 diabetes.

people who meet the recruitment criteria, will be invited to attend for a single fasted 2 hour visit at our research facility. during the visit we will record details of their diabetes history as well as their general health and undertake blood and urine tests. at the end of the visit their participation will be complete. we will contact them later to discuss results of specialist blood tests and whether or not they have mody, if they have had genetic testing performed.

Eligibility criteria:
inclusion criteria: * diagnosed with diabetes on the basis of fasting glucose and/or oral glucose tolerance test and/or hba1c as per who criteria. * diagnosed with diabetes between 6 months and 30 years of age. * south asian ancestry- defined as self-reported ancestry and at least 2 grandparents from the indian subcontinent (india, pakistan, bangladesh or sri lanka). * european ancestry - defined as self-reported ancestry and at least 2 grandparents from within europe. exclusion criteria: * an established secondary cause of diabetes exists (for example recurrent pancreatitis, pancreatectomy, new onset diabetes after transplantation, cushing's syndrome, acromegaly, steroid induced). * enrolled in another study. * have active malignancy or under investigation for malignancy.
effectiveness evaluation of panax ginseng, vitamins and minerals in improvement of stress and fatigue

Conditions: Reduction of Stress and Fatigue

Summary: we hope that with the drug, patients obtain reduced levels of stress and fatigue, according to the scales that we use in the study. hopefully the results of the treated group are significantly higher than the control group (placebo).


Eligibility criteria:
inclusion criteria: * agree with all study procedures, signing the ic in two ways; * patients older than 18 years, male or female, regardless of ethnicity or social class; * presence of mild to moderate stress, confirmed with the stress symptom inventory (iss); * presence of staff fatigue with a score greater than 36 according to the fatigue severity scale (fss). exclusion criteria: constitute exclusion criteria of the study: * participation in clinical trials in the 12 months preceding the survey; * current treatment with drugs that are stimulants or central nervous system depressants such as hypnotics, anxiolytics, antipsychotics, antidepressants, statins and muscle relaxants; * alternative therapies that scientifically, or have no influence in the tables of stress or fatigue as color therapy, acupuncture or relaxing massages; * treatment psychotherapeutic medication or not; * current treatment or prediction of treatment with oral anticoagulants (due to interaction with the tocopherol); * women who are pregnant or lactating; * patients with lactose intolerance; * patients allergic to soy or peanuts; * chronic renal failure; * patients using other multivitamins or individual vitamins such as vitamin d and / or a. * chronic alcoholism; * patients with clinical diagnosis of diseases causing severe chronic pain or adversely affect the clinical interpretation as fibromyalgia, multiple sclerosis, neuropathies and myopathies; * patients with hypothyroidism or hyperthyreosis diagnosed clinically; * patient history and physical examination suggestive of severe hepatorenal failure; * patients with decompensated diabetes mellitus (fasting glucose above 180 mg / dl); * patients undergoing treatment for cancer; * amendment of the routine of life during the study as early vacation or suspected change in working hours; * patients with complaints of excessive sleepiness caused by organic disease such as sleep apnea and morbid obesity (bmi above 35); * history of hypersensitivity to any component of the product under investigation; * any finding of clinical observation (clinical history or physical examination) that is interpreted by the physician investigator as a risk to the patient's participation in the study.
effect of a spice blend on cardiovascular risk factors and diet satisfaction

Conditions: Cardiovascular Disease; Inflammation

Summary: this study is a randomized 3-period crossover, controlled feeding study designed to evaluate the effects of the most commonly consumed spices in the u.s. on cvd risk factors, inflammation \& immune function, and diet satisfaction in participants at risk for cvd.

a 3-period randomized crossover controlled-feeding study will be conducted. participants will be randomly assigned to receive each 4-week treatment (diet) in random order. each test diet period will be separated by a standard 4-week compliance break. data collection will be conducted across at baseline (start of study) and the end of each diet period to assess the effects of chronic spice consumption on selected cardiovascular endpoints.

Eligibility criteria:
inclusion criteria: * overweight or obese (25-35kg/m2) * non-smoking * male or female * waist circumference \>= 94cm for men and \>=80cm for women * at least one other of the following: ldl- cholesterol \>130mg/dl; crp \>1mg/l; triglycerides \>=150mg/dl; hdl \ = 130mmhg or diastolic \>= 85mmhg; fasting glucose \>=100mg/dl exclusion criteria: * diabetes (fasting glucose \>126mg/dl) * hypertension (systolic blood pressure \>160mmhg or diastolic blood pressure \>100mmhg) * prescribed anti-hypertensive or glucose lowering drugs * established cardiovascular disease, stroke, diabetes, liver, kidney or autoimmune disease * use of cholesterol/lipid lowering medication or supplementation (psyllium, fish oil, soy lecithin, phytoestrogens) and botanicals * pregnancy or lactation * weight loss of \>=10% of body weight within the 6 months prior to enrolling in the study * vegetarianism
pm8002 in combination with paclitaxel compared with chemotherapy as second-line treatment in small cell lung cancer

Conditions: SCLC

Summary: pm8002 is a bispecific antibody targeting pd-l1 and vegf. this study will evaluate the efficacy and safety of pm8002 in combination with paclitaxel as second-line treatment for sclc

this multicenter, randomized, open-label phase iii study will evaluate the efficacy and safety of pm8002 in combination with paclitaxel versus investigator's choice (topotecan or paclitaxel) as second-line treatment for subjects with sclc.

Eligibility criteria:
inclusion criteria: 1. voluntary participation in this clinical study; full understanding of the study and voluntary signing the informed consent form; willing to follow and abling to complete all trial procedures; 2. age ≥18 years but ≤75 years; 3. histologically or cytologically confirmed sclc; 4. advanced sclc that has progressed or replased after first-line platinum-containing chemotherapy (extensive-stage patients must have received immune checkpoint inhibitors); 5. having adequate organ functions; 6. the eastern cancer cooperative group (ecog) performance score of 0 or 1; 7. life expectancy of 12 weeks or more; 8. having at least one measurable tumor lesion according to recist v1.1; exclusion criteria: 1. history of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs; 2. previous treatment with paclitaxel or topotecan or anti-vascular endothelial growth factor (vegf) target drugs; 3. current presence of severe superior vena cava syndrome and spinal cord compression; 4. adverse events resulting from prior anti-tumor therapies should be assessed and graded according to the ctcae 5.0 criteria, subjects whose aes have not returned to grade 1 or below; 5. evidence of significant clotting disorder or other significant bleeding risk; 6. history of severe, uncontrollable, or active cardiovascular diseases within 6 months; 7. current presence of uncontrollable pleural, pericardial, and peritoneal effusions; 8. human immunodeficiency virus (hiv) infection or known acquired immunodeficiency syndrome; 9. history of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation; 10. history of alcohol abuse, psychotropic substance abuse or drug abuse; 11. pregnant or lactating women; 12. other conditions considered unsuitable for this study by the investigator.

Keywords: second-line
effectiveness of antibiotic delivery via bio-absorbable sponge

Conditions: Paranasal Sinus Disease

Summary: this study will evaluate the efficacy of a nasopore sponge dressing soaked in bacitracin vs a sponge soaked in saline / and the administration of oral antibiotics.

same as above

Eligibility criteria:
inclusion criteria: * patient having primary or revision sinus surgery. aged 18 years or older.patients must have middle meatus easily identified. the type of surgery will not be influenced by the participation in this study. exclusion criteria: * age less then 18 * known sensitivity to bacitracin * pregnancy
desipramine for improving cellular signaling and decreasing symptoms of major depression

Conditions: Depression

Summary: this study will determine the effectiveness of desipramine in improving cellular signaling, and thereby decreasing symptoms of depression in people with major depressive disorder (mdd).

mdd is a serious mental illness that can interfere with a person's ability to eat, sleep, work, and enjoy activities that were once pleasurable. it is characterized by several symptoms, including as the following: persistent sad, anxious, or "empty" mood; feelings of hopelessness or pessimism; and feelings of guilt, worthlessness, or helplessness. the receptor-g protein-adenylate cyclase enzyme complex (ac enzyme complex) is a major cell signaling system in the brain, blood, and other tissues in the body. changes in this signaling system among blood cells have been observed in people with major depressive disorder. research has shown that treatment with the benzodiazepine alprazolam corrects the signaling problem, and thereby improves symptoms of mdd. this study will determine whether impairments in the ac enzyme complex exist among depressed individuals. this study will also evaluate the effectiveness of desipramine, an antidepressant, in improving blood cell signaling, and thereby decreasing symptoms of depression in people with major depressive disorder. both healthy and depressed participants will be recruited for this study. all depressed participants in this study will first be assessed for depression severity using the hamilton depression rating scale. if eligible for the study, participants will be examined to determine ac enzyme complex functioning in both platelets and mononuclear leukocytes. a cohort of the depressed participants will be treated with desipramine. they will be examined to determine the drug's effect on ac enzyme complex functioning, as well as its effect on mdd symptoms, at weeks 1, 4, and 6.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of mdd (as defined by scid \[dsm iii-r\] and a score of at least 15 on the 21-item hamilton depression scale) * able to swallow tablets, give urine and blood samples, and participate in periodic evaluations during the study * healthy volunteers show no current axis i or axis ii disorders and score less than 8 on the hamilton depression scale exclusion criteria: * use of any of the following medications within the 2 weeks prior to study entry: psychoactive medication; aspirin; or nonsteroidal anti-inflammatory agents * any alcohol or drug abuse within the 6 months prior to study entry * any major medical disorder

Keywords: major depressive disorder mdd
study evaluating the effects of bazedoxifene/conjugated estrogens on endometrial safety and postmenopausal osteoporosis

Conditions: Menopause; Osteoporosis

Summary: the purpose of this research study is to evaluate the safety and effectiveness of this investigational drug for the treatment of menopausal symptoms while protecting the endometrium (uterine lining) and preventing postmenopausal osteoporosis. subject participation will last approximately 14.5 months.


Eligibility criteria:
inclusion criteria: * generally healthy, postmenopausal women, aged 40 to 64 seeking treatment for menopausal symptoms * at least 12 months of spontaneous amenorrhea, or 6 months spontaneous amenorrhea with follicle-stimulating hormone (fsh) levels \> 40 miu/ml * intact uterus exclusion criteria: * use of oral estrogen, progestin, androgen, or selective estrogen receptor modulator (serm) containing drug products within 8 weeks before screening * a history or active presence of clinically important medical disease: eg. cardiovascular disease (stroke, heart attack), chronic renal or liver disease, breast cancer, etc.

Keywords: postmenopausal women bazedoxifene/conjugated estrogens
pilot study of the safety and efficacy of oxandrolone in the prevention and treatment of malnutrition in infants

Conditions: Malnutrition

Summary: oxandrolone is an anabolic steroid, marketed in the united states as an adjunctive therapy to combat weight loss resulting from chronic infection, extensive surgery, severe trauma, protein catabolism associated with prolonged administration of corticosteroids, and for the relief of bone pain accompanying osteoporosis. in children, it has been used to prevent and treat growth failure associated with severe burns (≥ 40% of total body surface area), duchenne muscular dystrophy, turner's syndrome, constitutional delay of growth and puberty, and chronic wasting in hiv-positive pediatric patients. other applications in children have included treatment of central idiopathic precocious puberty, hereditary angioedema, and bilateral congenital anorchia. growth failure is a common feature of infants with complex congenital heart disease, and can adversely affect outcome. this therapy has not been previously implemented in neonates thus we will evaluate the safety and efficacy of administering oxandrolone to improve growth in neonates with complex congenital heart disease who have undergone surgical palliation or repair by collecting anthropometric measurements and pharmacokinetic data. neonates with hlhs or variant with planned norwood procedure. the primary aims of this pilot study are to assess safety and efficacy of oxandrolone in this population. our goal will be to enroll 5 patients in each phase of this pilot study. the incidence of adverse events will also be monitored and compared to untreated patients. enrollment will continue until the target of 20 total patients has been met.


Eligibility criteria:
inclusion criteria: * neonates with hlhs, with plan to undergo the norwood procedures exclusion criteria: * neonates with a birth weight ≤2.5 kg and gestational age ≥38 weeks (indicating intrauterine growth retardation), gestational age \< 35 weeks (premature infants), and/or chromosomal or recognizable phenotypic syndrome of non-cardiac congenital abnormalities associated with growth failure (e.g. trisomy 21, trisomy 13, noonan's syndrome, turner's syndrome) will be excluded from enrollment. neonates who will not be placed on the high risk feeding protocol postoperatively will also be excluded.

Keywords: neonates with hlhs or variant with plan to undergo norwood procedure
spring loaded tri-compartment unloader knee brace study

Conditions: Anterior Knee Pain

Summary: this study will examine clinical outcomes related to pain and function in patients with anterior knee pain (i.e. focal patella and/or trochlea cartilage defect(s), patellofemoral arthritis) before and after standard of care, non-surgical management with and without the addition of a tri-compartment unloader (tcu) knee brace during activities of daily living. randomly selected participants will wear a tcu brace for several weeks during physical therapy and activities of daily living that is designed to reduce compressive forces in all three compartments of the knee during weight-bearing flexion. our hypothesis is that tcu bracing will improve clinical outcomes relatednto pain and function.

patients in this study have been identified as good candidates by their physicians. as the study procedures closely follow the standard of care procedures in place, study participation presents little additional risk above and beyond the standard of care procedures. the study was designed to present the least risk possible consistent with sound research design. participants in this study will undergo standard of care x-rays that will help in eligibility determination. participants will be randomized to either group, and will have a 50% chance of receiving the brace. outcomes will be measured at baseline (before any intervention), 6 weeks after commencing rehabilitation at stanford, and 3 months after commencing rehabilitation at stanford. these outcome measures are collected using patientiq which is is being used at the clinic as part of standard of care. spring loaded tech is providing the tcu braces for the patients in this study at no cost.

Eligibility criteria:
inclusion criteria: 1. anterior knee pain that worsens when the knee is flexed and bearing weight 2. patellofemoral chondral defect(s) or patellofemoral arthritis detected with standard of care x-ray and/or mri 3. kellgren and lawrence grade 0-3 of pf joint 4. able to wear the tcu knee brace for a minimum of 3 hours per day 5. over 18 years old, can understand written english 6. coronal knee alignment within 7 degrees of neutral 7. must be able to fit within an off-the-shelf knee brace size provided by company 8. must complete physical therapy through stanford exclusion criteria: 1. surgical intervention definitely indicated (major mechanical symptoms/failed substantial previous conservative measures) on the affected knee within the next year 2. use of another brace designed to unload the knee or manage knee pain during the study 3. varus/valgus joint alignment \> 7 degrees 4. inability to be fit properly in an off-the-shelf brace provided by the company 5. bmi \>40 6. bilateral knee symptoms

Keywords: knee brace effectiveness
early sensory re-education of the hand with a sensor glove model

Conditions: Peripheral Nerve Injuries

Summary: the implementation of early sensory re-education (sr) techniques, aimed to preserve the cortical hand area, such as the use of audio-tactile interaction, becomes an important strategy to obtain also a better sensory function. the aim of this study was to investigate sensory function outcomes (threshold monofilaments, two-point discrimination test, sti and dash) and cortical responses (fmri) in patients submitted to an early protocol of sr of the hand with a sensor glove model. after surgical repair of median and/or ulnar nerves, 17 participants were divided into two groups: the training group, trained on the protocol with the sensor glove model, and the control group, untrained. after six-month follow-up, no difference was observed between groups, related to sensory function, especially tactile gnosis. despite this, the early training with this sensor glove model seems to provide some type of cortical audio-tactile interaction, contributing to previous studies that focus in early sr of the hand using the integration of different sensory modalities.


Eligibility criteria:
inclusion criteria: - injury of the ulnar and/or median nerves at the wrist or distal forearm level surgically repaired exclusion criteria: * neurological diseases * systemic diseases, which affected either directly or indirectly the central or peripheral nervous system * extensive traumas in the upper limbs

Keywords: peripheral nerves/lesions; hands; rehabilitation; fmri
a study of efficacy of new doses of xolair to protect from allergen challenge in groups of asthma patients defined by ige levels

Conditions: Asthma

Summary: this study was intended to demonstrate that patients with standard and high immunoglobulin e (ige) levels can be protected from allergen induced broncho-constriction by xolair


Eligibility criteria:
inclusion criteria: * male and female adult patients, body weight between 40-150 kg aged 18-65 years (inclusive) * patients diagnosed with asthma with forced expiratory volume (fev1) ≥65% of the predicted normal value for the patient * positive skin prick test to a specific allergen * patients had to demonstrate a provocative dose 20% fev1 decline (pd20) response to an aeroallergen in the graded allergen bronchoprovocation testing (abp) at screening exclusion criteria: * current active smokers * patients who have been hospitalized or had emergency treatment for an asthma attack in the 12 months prior to study start * history of bleeding disorders * history of drug allergy * pregnant women or nursing mothers * females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception (surgical contraception or double barrier methods (to be continued for at least two months following last dose) are acceptable). * sexually active males who have not been sterilized and are not using a condom * history of immunocompromise, including a positive hiv * a positive hepatitis b surface antigen (hbsag) or hepatitis c test result. * history of drug or alcohol abuse within 12 months of study start other protocol-defined inclusion/exclusion criteria may apply

Keywords: asthma allergen challenge bronchoprovocation methacholine challenge serum immunoglobulin e nitric oxide skin prick test
controlling and lowering blood pressure with the mobiushd™

Conditions: Hypertension

Summary: to perform post-market surveillance and evaluate the performance of the mobiushd system in subjects with primary resistant hypertension.

the calm-diem trial is an open-label, prospective, multicenter study for patients who have been selected for treatment with the mobiushd.

Eligibility criteria:
inclusion criteria: * mean 24-hour systolic abpm is ≥130 mmhg following at least 30 days on a stable antihypertensive medication regimen (no changes in medication or dose), and no more than 28 days prior to implantation. exclusion criteria: * known or clinically suspected baroreflex failure or autonomic neuropathy substudy eligibility criteria: a maximum of 16 patients will be enrolled in the sub-study at one site (universitair medisch centrum utrecht) inclusion criteria: - patients must be eligible for the main study and must have passed all calm-diem study inclusion and exclusion criteria at time of screening exclusion criteria: * use of anti-hypertensive drugs directly acting on the sympathetic nervous system that cannot be discontinued safely * underlying conditions that prohibit microneurography, performance of a valsalva maneuver and/or magnetic resonance imaging

Keywords: hypertension